CLASS II Device recall · Reported 27 Jul 2022 · FDA Enforcement Report

Genesis II Non-Porous Tibial Baseplate Size 5 Right recalled

Smith & Nephew is recalling Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186, distributed nationwide in the US. The recall was initiated on 27 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.

Quantity recalled31 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1418-2022
FDA event ID: 90547
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 27 Jun 2022
FDA classified: 20 Jul 2022
Reported: 27 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

27 Jun 2022	Recall initiated by company
20 Jul 2022	Classified by FDA	+23 days
27 Jul 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.

Where it was distributed

US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI.

Nationwide Arizona California Georgia Kansas Louisiana Michigan Minnesota Missouri Mississippi North Carolina New Jersey New York Oregon South Carolina Tennessee Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

Which lots are affected?

Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.

Where was it sold?

US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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